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Completed

NCT Number: NCT00757848

A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis

The purpose of this study is to investigate if treatment with AZD9668 for 28 days is effective in treating Cystic Fibrosis (CF) and if so how it compares to placebo (a substance which does not have any action).

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Copenhagen, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or post-menopausal or surgically sterile female patients
  • Have a clinical diagnosis of Cystic Fibrosis with lung function tests greater or equal to 40% of normal
  • Have normal renal function

Exclusion criteria

  • Lung transplant patients
  • Significant liver disease
  • Any other non-CF-related lung disease that may interfere with study assessments

Treatment and study plan

AZD9668

Drug

60 mg, oral tablet, twice daily for 28 days

AZD9668 Placebo equivalent

Drug

Match placebo to 60 mg, oral tablet, twice daily for 28 days

Primary outcomes

  1. Ratio of Sputum Absolute Neutrophil Count at End of Treatment Compared to Baseline

    Time frame: Baseline and Values from day 21 to 28

    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  2. Sputum Percentage Neutrophil Count

    Time frame: Baseline and Values from day 21 to 28

    Percentage of neutrophils in white blood cell count.Change from Baseline (mean of 2 baseline visits) to the end of the treatment period (mean of 2 visits at the end of the treatment)

  3. 24-hour Sputum Weight

    Time frame: Baseline and day 28

    Sputum weight (g) collected during 24 hour periods. Change from Baseline to day 28.

  4. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Baseline and day 28

    Forced Expiratory Volume in 1 second (L) as a measure of lung function.Change from Baseline to day 28.

  5. Slow Vital Capacity (SVC)

    Time frame: Baseline and day 28

    Slow Vital capacity (L) as a measure of lung function. Change from Baseline to day 28.

  6. Forced Expiratory Flow Between 25 and 75% of Forced Vital Capacity (FEF25-75%)

    Time frame: Baseline and day 28

    FEF25-75% (L) as a measure of lung function. Change from Baseline to day 28.

  7. Forced Vital Capacity (FVC)

    Time frame: Baseline and day 28

    Forced Vital Capacity (L) as a measure of lung function. Change from Baseline to day 28.

  8. Morning Peak Expiratory Flow (PEF)

    Time frame: Last 7 days on treatment

    Morning Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment

  9. Evening Peak Expiratory Flow (PEF)

    Time frame: The last 7 days on treatment

    Evening Peak Expiratory Flow (L/min) as a measure of lung function.Change from baseline value to mean of the last 7 days on treatment

  10. Bronkotest Diary Card Signs and Symptoms

    Time frame: The last 7 days on treatment

    The Bronkotest diary card includes 8 questions on signs and symptoms. Symptom scores were recorded for night-time symptoms, breathing, sputum colour, sputum amount, sputum type, wellbeing, and cough, generally scored on a scale from 0 (no symptoms) to 4 (worst symptoms). ANOVA models were fitted to compare the change from baseline between AZD9668 and placebo for each question separately, with a p-value of 0.1 considered statistically significant. The number of number of these 8 measures with significant differences is reported.

  11. Cystic Fibrosis Questionnaire (CFQ-R) - Quittner

    Time frame: Baseline and day 28

    Cystic Fibrosis Questionnaire Overall Score as a measure of quality of life and disease symptoms. Scores range from 0 to 100, with higher scores indicating better health. The overall score is the sum of 12 subscores. Change from baseline to day 28.

Secondary outcomes

  1. Ratio of Sputum Tumour Necrosis Factor Alpha (TNF α) at End of Treatment Compared to Baseline

    Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.Values from day 21 to 28

    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  2. Ratio of Sputum Interleukin 6 (IL-6) at End of Treatment Compared to Baseline

    Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.

    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  3. Ratio of Sputum Interleukin 1 Beta (IL-1β) at End of Treatment Compared to Baseline

    Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits

    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  4. Ratio of Sputum Regulated on Activation, Normal T Cell Expressed and Secreted (RANTES) at End of Treatment Compared to Baseline

    Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits.

    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  5. Ratio of Sputum Monocyte Chemoattractant Protein-1 (MCP-1) at End of Treatment Compared to Baseline

    Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits

    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  6. Ratio of Sputum Interleukin 8 (IL-8) at End of Treatment Compared to Baseline

    Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits

    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  7. Ratio of Sputum Leukotriene B4 (LTB4) at End of Treatment Compared to Baseline

    Time frame: End of treatment values from 2 visits (day 21 to 28) and baseline values from 2 visits

    Ratio of the mean of 2 visits at the end of the treatment period to the mean of 2 baseline visits

  8. Ratio of Urine Desmosine (Free) (Normalised for Creatinine) at End of Treatment Compared to Baseline

    Time frame: Baseline and day 28

    Ratio of day 28 to baseline

  9. Ratio of Urine Desmosine (Total) (Normalised for Creatinine) at End of Treatment Compared to Baseline

    Time frame: Baseline and day 28

    Ratio of day 28 to baseline

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients With Cystic Fibrosis

Acronym: INCA

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 23, 2008
Registry last updated
Aug 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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